In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis

Melanoma Clinical Trial

Official title:

In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785369
• Other study ID #: LI058054
• Secondary ID: 5R44CA058054-06
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: October 2, 2012
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2012
• Source: Lucid, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an imaging technology called in vivo reflectance confocal microscopy. This technology uses low intensity laser to image below the surface of the skin. The confocal images of the suspicious skin lesion will be examined. The goal of this study is to compare the results of the confocal image examination to the pathologic diagnosis of the skin lesion.

The technique being evaluated in this study uses reflectance confocal microscopy in vivo. The term "in vivo" means in/on a living subject. In this study you will be the living subject and the confocal microscope will be placed on your skin to look at your skin lesion. The confocal microscope uses a weak laser light and a sophisticated lens to image the individual cells that make up the skin. Your lesion will be photographed with high resolution photography.

Description:

Patients will be imaged with the VivaScope 1500 reflectance confocal microscope during a single patient visit. The lesion will be photographed with high resolution photography and a high resolution dermoscopic device.

The lesion will then be prepared for RCM imaging. A skin contact device consisting of a metal ring and window will be applied to the skin surrounding the lesion of interest with a disposable medical grade adhesive. A wetting solution will be placed onto the skin. The wetting solutions include a high index oil such as a clear cosmetic oil or mineral oil. A wetting solution such as ultrasound gel will also be placed on the lens of the microscope. Application of these agents diminishes artifacts caused by light scattering at the skin surface. RCM images of the lesion will be captured through the window/contact device using the Vivascope 1500 reflectance confocal microscope provided by Lucid, Inc. Two types of images will be collected, mosaics and stacks. Mosaics are 12x12 confocal images that are optically combined or "stitched" together to create a seamless representation of a 6mm x 6mm total area at specific depths within the skin. Stacks are 0.5mm x 0.5mm confocal images taken at 5 micron intervals from the keratin layer to the superficial dermis. Mosaics and stacks will be acquired for the skin lesion. The total estimated imaging time for a patient in this study is about 10 minutes for each lesion. More than one lesion may be imaged per patient.

After the imaging is complete, the lesion will be biopsied. All lesion images will be saved on a network server for later review and analysis. All imaging will be completed by trained research staff familiar with confocal imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing biopsy for a pigmented lesion suspicious for malignancy.

• Patients undergoing biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).

• Ability to give informed consent.

Exclusion Criteria:

• Lesion suspicious for melanoma located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).

• The lesion (suspicious for melanoma) is located on soles of the feet or palms of the hands.

• Inability to give informed consent.

• Known hypersensitivity to adhesive rings.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lentigo
• Lentigo Maligna
• Melanoma
• Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Reflectance confocal microscopy
Reflectance confocal microscopy (VivaScope 1500)

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	Hauppauge	New York
United States	Loma Linda University	Loma Linda	California
United States	VA Loma Linda Health Care System	Loma Linda	California
United States	Memorial Sloan-Kettering Cancer Center	Manhattan	New York
United States	Skin and Cancer Assoicates	Plantation	Florida
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (7)

Lead Sponsor	Collaborator
Lucid, Inc.	Harvard University, Loma Linda University, Memorial Sloan Kettering Cancer Center, Skin and Cancer Associates in Plantation,Fl., University of Rochester, VA Loma Linda Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis.		Once while on study	No
Secondary	To assess interobserver variability associated with interpreting confocal images for detecting cutaneous melanoma and to assess confocal correlations in a qualitative manner.		Once while on study	No